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Wednesday, December 2, 2015

FDA Approves One Naloxone Nasal Spray, But Not Two

Prescription opioid and heroin overdoses are tragic events that often times result in loss of life. The United States has been in the grips of an opioid epidemic for over a decade now, an illicit drug use crisis that is unprecedented. Fortunately, opioid overdoses do not need to have a fatal outcome, thanks to the drug naloxone - sold under the brand name Narcan.

Naloxone is a μ-opioid receptor competitive antagonist. When administered the drug blocks those receptors and causes rapid onset of withdrawal symptoms. If given to an overdose victim promptly, the drug can reverse the effects of an overdose - potentially saving a life. Clearly, the national opioid epidemic has been cause for making the life-saving medicine more available and easier to use. Until recently, naloxone was, for the most part, only available in emergency room settings in the form of injection. Naturally, naloxone in injection form limited the reach of the drug, which is why many law enforcement officers and paramedics were permitted to carry naloxone nasal spray kits. However, naloxone was not approved by the Food and Drug Administration (FDA) to be used in nasal spray form, despite the fact that administering the drug in an atomized form is easier to use and can be implemented more quickly.

Last month, the FDA finally approved a nasal spray version of the drug made by Adapt Pharma, according to a FDA press release. The company has stated that it will offer the spray at a discount to emergency workers, police and firefighters. Interestingly, the agency chose not to approve a second nasal spray version of naloxone made by Indivior, Reuters reports. In a news release, the company stated that the FDA’s response “was principally focused on clinical pharmacology.”

“We are closely reviewing the FDA’s response,” said Shaun Thaxter, Chief Executive Officer, Indivior PLC. “Our commitment to improving patient outcomes remains steadfast, and as part of this, our work with stakeholders across communities will continue.”

It probably goes without saying that the need for greater access to this life saving drug is crucial. Every life saved, translates to another opportunity for an addict to seek help for their opioid addiction. Whiteside Manor has a highly trained staff on hand, who are fully equipped to help people learn how to live a life free from opioids.